Home Oxygen Liquefaction System Receives FDA Clearance

DENVER–An in-home system that converts gaseous oxygen to liquid
form received FDA clearance late last month.

In-X Corp.’s Home-Away system enables patients with long-term
oxygen therapy to produce liquid oxygen in their home. The system
“will enable patients on LTOT to remain mobile and maintain their
quality of life,” said company President Doug Powell.
“Additionally, it is exciting news for home health care providers
because it eliminates costly and time-consuming deliveries
….”

Powell explained that the system takes “feed flow from an oxygen
concentrator and sends a portion of it through a cryogenic cooling
device that chills to the temperature at which oxygen condenses
[into liquid form].” The liquid oxygen is stored until it’s ready
to be transfilled into a portable, 4.2-pound unit that can give a
typical patient six to eight hours worth of oxygen.

“This basically gives the patient an unlimited supply of liquid
O2,” Powell said.

He added that the new technology is in line with the industry’s
push to lower costs through fewer in-home deliveries. For example,
where the company is located in Denver, “to run a truck in the
mountains once a week to deliver oxygen is very expensive,” he
said. “As cost goes up to deliver and the reimbursement goes down,
[providers] are going to look at that radius [of the coverage area]
they’re servicing and tighten up. So what will happen to the folks
in those outer areas?”

The FDA clearance has been a long time coming, Powell said. A
prototype unit was introduced about five years ago, and “we’ve gone
through a number of iterations based on that early concept,” he
explained. “Every time you make a change, you have to re-apply
[with the FDA].”

The company had hoped to gain FDA approval for the product in
time for Medtrade Spring in early April. Now, they’re anticipating
having the system ready for sale during the last quarter this year
with delivery to begin in early 2006.

With the product finally on its way to the market, observers say
they are waiting to see if it meets the kind of success other home
oxygen filling systems have experienced during the last year.
Elyria, Ohio-based Invacare Corp. attributed growth in its North
American respiratory sales–43 percent over all of 2004 and 16
percent during first quarter 2005–to its HomeFill product line,
along with strong concentrator sales. Meanwhile, Chatsworth
Calif.-based Chad Therapeutics said shipments of its Total O(2)
Delivery System for the third quarter, which ended Dec. 31, had
tripled over prior-year results.